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OpenTrials
Completed

NCT Number: NCT06354686

Characterizing the Scalp Tolerability of TMS

The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the knee as a surrogate location to safely trial tolerability of novel TMS parameters.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ages 18 years and older.
  • Capable to give informed written consent, ability to understand study procedures, and ability to comply with procedures for the entire length of the study.
  • Individuals with and without prior exposure to TMS are eligible (including individuals who have received TMS to treat depression).

Exclusion criteria

  • Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
  • Contraindication for scalp sensitivity and tolerability testing (e.g., sunburn, active headache, history of frequent and severe headaches).
  • Contraindication for knee sensitivity and tolerability testing (e.g., current knee injury or ongoing complications from prior history of knee surgery), unless knee testing skipped at the investigators' discretion.
  • Contraindication for participants with metal in both knees, unless knee testing skipped at the investigators' discretion.
  • Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
  • Dementia or other cognitive disorder making unable to engage in study.
  • Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness.
  • Taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.).
  • Any medication or substance use that significantly impacts sensory and tolerability measures based on the investigators' review of dosing and effect (e.g., topical anesthetics, botulinum toxin injections, ketamine, NSAIDS, opioids, anticonvulsants used in pain management, etc.).
  • Current, planned, or suspected pregnancy.
  • Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.).
  • Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).

The investigators will exclude the following individuals:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Treatment and study plan

TMS Tolerability

Device

The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the feasibility of the knee as a surrogate location to safely trial TMS parameters.

Primary outcomes

  1. Tolerability of TMS - Scalp Location

    Time frame: 3-36 months

    Characterization of the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) using the McGill Pain Questionnaire and;

  2. Tolerability of TMS - Stimulation parameters (single pulse, 10 Hz, theta burst).

    Time frame: 3-36 months

    Characterization of the tolerability of TMS by stimulation parameters (single pulse, 10 Hz, theta burst) using the McGill Pain Questionnaire.

Secondary outcomes

  1. Tolerability of TMS (Knee Location)

    Time frame: 3-36 months

    Evaluation of the knee as a surrogate location to safely trial tolerability of TMS parameters. Qualitative descriptors (McGill Pain Questionnaire) will be selected by participants from a list of words and used to describe the quality of the TMS pulse (e.g. flickering, pricking, sharp, pinching, tugging, tingling, etc.).

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Characterizing the Scalp Tolerability of Transcranial Magnetic Stimulation by Location and Stimulation Parameters

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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